Health product recall

Heartsine Samaritan PAD (2020-01-13)

Starting date:
January 13, 2020
Posting date:
January 31, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72231

Last updated: 2020-01-31

Affected Products

Heartsine Samaritan PAD

Reason

HeartSine Technologies, now part of Stryker, is conducting a Field Action for specific HeartSine samaritan PAD 450P devices that have been shipped into countries where registration approval has not been received. HeartSine Technologies/Stryker has become aware [during a review of device tracking data Spetember 2019] that thirty SAM 450P devices [sold to customers in the USA] are now listed in Canada as the end user location. The SAM 450P device is not registered for sale in Canada.

Affected products

Heartsine Samaritan PAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SAM 450P

Companies
Manufacturer

Heartsine Technologies Ltd.

Canberra House, 203 Airport Road West

Belfast, Northern Ireland

BT3 9ED

UNITED KINGDOM